SPA-CC_PWS.pdf

Performance Work Statement (PWS)

Single Point of Access-Coordinating Center

(SPA-CC)

April 4, 2017

Performance Work Statement (PWS) Single Point of Access-Coordinating Center (SPA-CC)

VISION STATEMENT

To operate a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients and allow health care professionals and patients to search electronically for cells derived from adult marrow donors and cord blood units through a single point of access, in support of the Department of Health and Human Services (HHS) and its agents in their oversight role of the C.W. Bill Young Cell Transplantation Program.

1 INTRODUCTION

The C.W. Bill Young Cell Transplantation Program (Program), Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration (HRSA), is seeking a Contractor to operate the Single Point of Access- Coordinating Center (SPA-CC).

1.1 Mission

The Program supports HRSA's mission to improve access to quality healthcare and services by supporting studies and demonstration and outreach projects for the purpose of increasing cord blood donation and volunteer adult donors to ensure genetic diversity and allowing professionals and patients to search electronically for cells derived from adult marrow donors and cord blood units through a single point of access.

1.2 Scope

The purpose of this contract is to establish and maintain the Single Point of Access- Coordinating Center (SPA-CC) a component of the C.W. Bill Young Cell Transplantation Program (Program). In performing the activities of the SPA-CC, the Contactor shall 1) establish a system for health care professionals and patients to search electronically for cells derived from adult marrow donors and cord blood units through a single point of access (SPA);

The Contractor shall:

1. Establish and maintain an electronic single point of access for patients and health care providers to search for cells from potential marrow donors and cord blood units.

2. Establish a system for identifying, ranking, matching, and facilitating the distribution of donated cord blood units and adult bone marrow that are suitably matched to candidate patients;

3. Carry out informational and educational activities for the recruitment of volunteer adult bone marrow donors and mothers of donors of cord blood units, giving priority to increasing underrepresented donor populations and considering racial and ethnic minority groups.

4. Facilitate tissue typing and infectious disease marker testing of adult volunteer donors and cord blood units;

5. Facilitate bone marrow and cord blood unit transplants;

6. Facilitate the collection, verification, and analyses of HLA data from unrelated bone marrow and cord blood transplants and ensure such information is adequately displayed for physician searches on behalf of patients

7. Support and expand new and existing studies and demonstration and outreach projects for the purpose of increasing bone marrow and cord blood unit donation and collection;

8. Coordinate with transplant centers, donor centers, and cord blood banks to support informational and educational activities;

9. Provide information to physicians, other health care professionals, and the public regarding bone marrow and cord blood transplants from donors as a treatment option; and

10. Certify that NCBI cord blood units meet eligibility criteria for HRSA funding.

1.3 Background

In 1987, the National Bone Marrow Donor Registry (NBMDR) was initiated through a congressionally-directed grant from the U.S. Department of the Navy and formally established in 1990 as a responsibility of the U.S. Department of Health and Human Services (HHS), with oversight initially by the National Institutes of Health (National Heart, Lung, and Blood Institute) and, since 1994, by HRSA. The Registry contract encompassed, among other activities, the recruitment and tissue typing of adult volunteer donors; the facilitation of the selection of donors for particular patients, the distribution of blood stem cells to transplant centers; the provision of case management and advocacy services for patients; the coordination of an international blood stem cell transplant; and the development of contingency plans to address events that may cause marrow toxic injuries.

In 2005, Section 3 of the Stem Cell Therapeutic and Research Act (Public Law (P.L.)

109-129, as amended by P.L. 111-264 (in 2010), and reauthorized by P.L. 114-104 (in 2015)), amended the Public Health Service Act to require the HHS Secretary, acting through HRSA, to rewrite provisions that required the HHS Secretary to establish and maintain the National Bone Marrow Donor Registry. The provisions were rewritten to establish and maintain the C.W. Bill Young Cell Transplantation Program (Program), the successor to the NBMDR, to increase the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood.

The Public Health Service Act (Act) (Section 3) also requires the Secretary to enter into contracts with qualified cord blood banks to assist in the collection and maintenance of at least 150,000 new units of high-quality cord blood to be made available for transplantation through the Program. Among other things, the Act requires recipients of these contracts to submit data in a standardized electronic format for inclusion in the stem cell therapeutic outcomes database maintained under section 379A of the Public

Health Service Act, as amended by this Act. Section 2 of the Stem Cell Therapeutic and Research Act requires the Secretary to establish an Advisory Council to advise the Secretary on matters related to Program activities and requires the Secretary to recognize one or more organizations to accredit banks participating in the Program.

In the 2015 reauthorization of this Act, The Secretary of Health and Human Services, in consultation with the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Administrator of the Health Resources and Services Administration, including the Advisory Council on Blood Stem Cell Transplantation established under section 379(a) of the Public Health Service Act (42 U.S.C. 274k(a)), and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the C.W. Bill Young Cell Transplantation Program (established under such section 379), in addition to the continuation of ongoing activities. Not later than June 30, 2019, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the appropriateness of such new types of therapies for inclusion.

1.4 Overview of Blood Stem Cell Transplantation

Bone marrow and peripheral blood have been the predominant sources of blood stem cells for patients in need of transplantation to treat various life-threatening disorders.

Initially, transplants were performed between identical twins. Later, transplants were performed with cells from genetically matched siblings. Advances in medicine and immunology permitted transplants with cells from donors closely matched in tissue type but not related to the patients. This was critical because each year nearly 18,000 people in the U.S. are diagnosed with life-threatening illnesses where blood stem cell transplantation from a matched donor is the best treatment option. Often, the ideal donor is a suitably-matched family member, but only 30 percent of people have a fully-matched relative. The other 70 percent, or approximately 12,600 people, often search for a matched unrelated adult donor or umbilical cord blood unit. The National Bone Marrow Donor Registry was created to recruit adult volunteer donors and to facilitate unrelated donor transplants. Even with over 13.6 million adults on the registries worldwide, the close tissue matching required with adult donors has left many patients without a suitably matched unrelated adult donor. This is especially true for racial and ethnic minorities, mainly because they possess more diverse tissue types.

Umbilical cord blood has been shown to contain a high concentration of blood stem cells and thus offers another source of blood stem cells for hematopoietic reconstitution.

Importantly, research indicates that blood stem cells from cord blood can result in successful transplants with a less perfect match in tissue type between the donor and recipient than is needed with adult donors. An adequate cell dose relative to the patient’s weight is critical for cord blood transplants, and research is ongoing to further define the role of cord blood in transplanting larger patients.

1.5 Period of Performance

The period of performance for the contract is four years, which includes one base year and three option years.

2 GENERAL REQUIREMENTS

2.1 Contract Administration and Management

Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the contract requirements.

The Contractor shall establish processes and assign appropriate resources to effectively administer the requirements. The Contractor shall respond to Government requests for contractual actions (e.g., provide budget documents, business plans, statistical data, etc.) in a timely fashion. The Contractor shall have a single point of contact between the Government and Contractor personnel assigned to support the contract. The Contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to work on the requirement.

2.2 Subcontract Management

The Contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The prime Contractor shall manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. Contractors may add subcontractors to their team after notification to the Contract Specialist (CS), Contracting Officer (CO), and Contracting Officer Representative (COR).

2.3 Contractor Personnel, Disciplines, and Specialties

The Contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The Contractor shall match personnel skills to the work or task with a minimum deployment of resources. Pursuant to the Key Personnel clause (HHSAR 352.237-75), the following individual(s) is (are) designated as Key Personnel and considered to be essential to the work being performed under this contract: Project Director, Medical Director, Medical Consultant, Deputy Project Director of Information Systems, Deputy Project Director for Community Recruitment, and Histocompatibility Expert.

3 PERFORMANCE REQUIREMENTS

3.1 Contract Administration Requirements

3.1.1 Attend Initial/Kick-off Meeting - The Contractor shall meet with the COR, and other Government staff, to review the requirements and deliverable schedule for the contract. This initial meeting will be held in-person in Rockville, Maryland and will occur within 14 days of the effective date of the contract (EDOC). The Contractor shall develop the meeting agenda to the COR for approval prior to the meeting. The contractor shall provide the meeting minutes within seven (7) days after the meeting.

Performance Standard(s)

a) Initial/kick-off meeting minutes are submitted to the COR within seven (7) days after the initial/kick-off meeting.

b) Meeting completed within one business day. Key Stakeholders must be present.

c) Meeting agenda: Time slots are divided allow meaning discussion of each topic area,

d) Meeting Minutes; inclusive all discussion topics per the agenda, Meeting members, actions items with due dates, and no more than one revision after COR’s comments.

Deliverable(s) D00 Initial/Kick-off meeting agenda D00 Initial/Kick-off meeting minutes

3.1.2 Attend Quarterly COR Meetings - The Contractor shall attend quarterly meetings, via remote conference, with the COR to discuss milestones, progress and challenges related to the contract, and provide recommendations on improvements to the SPA-CC structure and processes to increase efficiency and effectiveness of the SPA-CC functions. The Contractor shall establish the agenda seven (7) days prior to the meeting and submit related background materials for the meeting to the COR for approval. The contractor shall submit the meeting minutes within seven (7) days after the meeting for approval by the

COR.

a) Quarterly meeting agenda is submitted to the COR seven (7) days prior to the quarterly meeting.

b) Quarterly meeting minutes are submitted to the COR within seven (7) days after the quarterly meeting.

D00 Quarterly meetings (remote conference) D00 Quarterly meeting agenda D00 Quarterly meeting minutes

3.1.3 Attend Ad Hoc COR Meetings - The Contractor shall convene via remote conference with the COR, no more than 12 times per year, for special or emergency situations that arise.. Either the Contractor or the COR may request the meeting; although, the requestor of the meeting is responsible for setting up the call, which includes determining which phone line will be used. The Contractor shall prepare meeting minutes five (5) days the meeting.

a) Ad hoc meeting agenda is submitted to the COR five (5) days prior to the ad hoc meeting.

b) Ad hoc meeting minutes are submitted to the COR within five (5) days after the ad hoc meeting.

D00 Ad hoc meeting agenda

D00 Ad hoc meeting minutes

3.1.4 Conduct Briefings – The Contractor shall conduct two briefings for the COR and other Government staff to discuss accomplishments and lessons learned.

The contractor shall conduct the In-person briefing two (2) weeks before the end of the base year and last option year. Briefing materials shall be submitted three

(3) weeks before the end of the base year and last option year for the COR’s approval.

Performance Standard(s)

a) In-person briefing conducted two (2) weeks before the end of the base year performance period and last option year performance period.

b) Briefing materials are submitted three (3) weeks before the end of the base year performance period and last option year performance period.

c) Recommendations focus on areas in the SPA-CC structure and processes that can be improved to increase efficiency and effectiveness of the SPA- CC function.

D00 Briefing materials, including recommendations

3.1.5 Establish Policy and Technical Direction of the SPA-CC – The Contractor shall establish policy and technical direction of the SPA-CC. The Contractor shall ensure that representatives from the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, and at least two representatives from the Division of Transplantation of the Health Resources and Services Administration, serve as ex-officio, non-voting members on the or to the governing body (e.g., Board or Executive Committee) that involves establishing or changing policy and technical direction of the SPA- CC. The Contractor shall also include representatives from the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, and at least two representatives from the Division of Transplantation of the Health Resources and Services Administration, as ex-officio, non-voting members of all committees, sub-committees, advisory and working groups relevant to this contract.

a) If the Contractor has a governing board (e.g., Board or other entity) making policy decisions regarding activities covered under this contract, the Contractor shall include two government representatives from HRSA and one from the Department of Defense in such meetings and deliberations to ensure compliance with contract requirements and government compliance.

b) Submit to the COR for approval proposed changes to policies and standards prior to their adoption and implementation. If no response is received from the COR within 30 days of submission of proposed changes, the updated polices will be considered to be approved by the COR and will go into effect.

c) Submit copies of policies and standards within 60 days after the EDOC and as changes are made, and at least annually in the absence of changes.1 At the discretion of the COR, the Contractor shall also provide an opportunity for public comment by posting proposed changes on their website.

d) Policy and technical direction encompass the following areas: listing criteria and requirements for tissue typing; receiving and conducting searches for suitably matched adult donors or cord blood units made available; informed consent of donor or donor mothers; donor screening;

donor advocacy; follow-up with biological parents for cord blood units with abnormal infectious disease markers and genetic testing; confidentiality of data; criteria for cord blood selection; donor selection criteria;

transportation of cord blood units and of marrow; integrating donor files;

and, criteria for participation (if applicable) in the SPA-CC.

e) Consult with the COR regarding proposed policy changes having an impact beyond day-to-day operations and ensure that such policies do not

1 All updated or revised processes shall be consistent with the current scope of work.

conflict with other policies established for other components of the C.W.

Bill Young Cell Transplantation Program and, in the case of National Cord Blood Inventory (NCBI) units, with HRSA requirements for such units.

f) Provide an assessment on the impact of the policy changes and whether the policy changes conflict with other policies.

g) Provide an opportunity for public comment by posting proposed changes on the Contractor’s website.

D00 Copies of policies and standards D00 Assessment of policy impact

3.1.6 Establish and Maintain Committees or Advisory Groups - The Contractor shall establish and maintain standing or ad hoc committees or advisory groups to advise and provide technical direction to the SPA-CC. The statement of purpose, goal(s), and objectives of each committee/advisory group demonstrate the need to establish the committee(s)/advisory group(s).

a) Committees or advisory groups include representatives from the

Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, and at least two representatives from the Division of Transplantation of the Health Resources and Services Administration, as ex-officio, non-voting members of the standing and ad hoc committees.

b) Submit report on the use of committees/advisory groups within 45 days after the EDOC, and annually thereafter. Report on the use of committees/advisory groups shall demonstrate the need to establish the standing or ad hoc committee or advisory group and include the statement of purpose, goal(s), objectives, and responsibilities and of each standing and ad hoc committee or advisory group.

c) Report on use of committees/advisory groups includes a description of standing or ad hoc committee or advisory group structure and composition, membership, and roles and responsibilities of its members.

d) Report on the use of committees/advisory groups includes the accomplishments of each committee/advisory group in the preceding year (not applicable during base year) and the mechanism by which each committee’s progress in meeting the goals of the Board (or equivalent body) is or will be assessed.

D00 Report on the use of committees

3.1.7 Avoid Conflict of Interest - The Contractor shall ensure that the Board (or appropriate governing body), standing committee(s), and ad hoc committee(s) implement procedures to prevent actual or perceived conflicts of interest for members. The Contractor shall have a process for ascertaining whether conflicts for specific members exist for matters coming before the Board (or governing body).

a) Submit written documentation of procedures to prevent conflicts of interest for each Board (or governing body), standing committee(s), and ad hoc committee(s) members within 60 days after the EDOC and annually thereafter.

D00 Written certification of procedures to prevent conflicts of interest for each governing body, committee, or advisory group

3.1.8 Lead Search and Distribution Working Group - The Contractor shall lead the Search and Distribution Working Group, as convened and/or approved by HRSA.

The Contractor shall be responsible for scheduling the meetings, preparing the agenda and background materials, and providing minutes of the meetings, and shall submit to the COR summary reports on the activities undertaken, the general discussions, the conclusions, and the solutions reached by the Search and Distribution Working Group.

a) Lead the Search and Distribution Working Group in establishing policies and procedures for: 1) receiving and conducting searches for suitably matched adult donors or cord blood units made available, including confirmation of search receipt from the SPA-CC; 2) requesting confirmatory tissue typing from stored cord blood units; 3) requesting additional blood samples from donors; 4) outlining the roles and responsibilities of each network organization, couriers, and others involved in facilitating the transport of blood stem cells; 5) scheduling donor medical evaluations and counseling sessions; 6) establishing the chain of custody from the blood stem cell collection site to the transplant center; 7) outlining the roles and responsibilities of each network organization; and

8) interpreting search results with patients and providing guidance regarding the their options.

b) The Search and Distribution Working Group members include at minimum other Program Contractors and the SPA-CC COR.

c) Schedule meetings at least 60 days prior to the meeting and in the first quarter of each performance period.

d) Submit agenda and previous meeting minutes at least 14 days prior to the meeting to participants.

e) Submit final meeting minutes to the COR within 14 days after the meeting.

f) Report on the activities of the Search and Distribution Working Group in the monthly progress report (Task 3.12.1).

D00 Monthly report on the activities of the Search and Distribution

Working Group (Task 3.12.1) D00 Meeting agenda, background materials, and meeting minutes

3.1.9 Lead Data Working Group – The Contractor shall lead the Data Working Group, as convened and/or approved by HRSA. The Contractor shall be responsible for scheduling the meetings, preparing the agenda and background materials, and providing minutes of the meetings, and shall submit to the COR summary reports on the activities undertaken, the general discussions, the conclusions, and the solutions reached by the Data Working Group. The Contractor shall allocate appropriate funds and personnel with the appropriate expertise to lead, staff, and participate in the Data Working Group.

a) The Data Working Group members include, at minimum, the other

Program Contractors and the SPA-CC COR.

b) Schedule meetings at least 60 days prior to the meeting and in the first quarter of each performance period.

c) Submit agenda and previous meeting minutes at least 14 days prior to the meeting to participants.

d) Submit final meeting minutes to the COR within 14 days after the meeting.

e) Report on the activities of the Data Working Group on a monthly basis in the monthly progress report (Task 3.12.1).

D00 Monthly report on the activities of the Data Working Group (Task

3.12.1) D00 Meeting agenda, background materials, and meeting minutes

3.2 Privacy and Confidentiality

3.2.1 Protect Privacy and Confidentiality - The Contractor shall maintain the policies, procedures, and safeguards to protect the privacy and confidentiality of donors and patients, and all information under this contract.

The Contractor shall ensure research activities, reports and publications protect the confidentiality of donors and patients. Information and data collection and dissemination, research activities, reports, patient advocacy services, case management, and publications shall be performed in compliance with Federal laws and regulations pertaining to privacy and informed consent, including:

1. Confidentiality provisions of Section 379 of the Public Health Service Act

2. The Privacy Act (P.L. 93-579)

3. Any other applicable Federal requirements, including requirements for compliance with the Health Insurance Portability and Accountability Act (HIPAA) and advance approval by the Office of Management and Budget (OMB) of Federal data collection activities. If OMB approval is required, the Contractor shall prepare all material as part of the application.

a) Maintain the policies, procedures, and safeguards to protect the privacy and confidentiality of donors and patients, and all information under this contract.

b) Ensure research activities, datasets, reports and publications protect the confidentiality of donors and patients.

c) Data collection and dissemination, research activities, reports, publications, and the compilation of datasets are performed in compliance with Federal laws and regulations pertaining to privacy and informed consent.

d) Report in writing to the COR, within 24 hours upon learning of them, any suspected or confirmed breaches of privacy or confidentiality that could result in media inquiries.

e) Report to the COR all (includes those identified in d)) suspected or confirmed breaches of privacy and confidentiality in the monthly progress report (Task 3.12.1)

D00 Policies and description of procedures and safeguards to protect the privacy and confidentiality of donors and patients, and all information under this contract

D00 Report on suspected or confirmed breaches of privacy or confidentiality

D00 Monthly progress report (Task 3.12.1)

3.3 Coordinate Transplantation Network

3.3.1 Link Transplant Centers with Donors and Cord Blood Units - The Contractor shall prepare a plan for coordinating a network of organizations to facilitate the identification and recruitment of volunteer adult donors to serve as bone marrow donors, to facilitate the selection and distribution of cord blood units, and to increase the efficiency of operations of that network.

Organizations outside of the U.S. appropriately may participate in the SPA-CC to increase patient access to cord blood stem cells and bone marrow transplants and to facilitate the collection of data regarding patients who reside outside the U.S.

a) Within 45 days after the EDOC, submit a plan to coordinate a network of organizations to facilitate the selection and distribution of cord blood units and facilitate the identification and recruitment of volunteer adult donors to serve as bone marrow donors for physicians searching on behalf of patients. Plan shall contain a preliminary list of network participants.

b) Plan shall include a timeline for implementation, objective measures of effectiveness of the plan, an annual assessment of the processes and procedures used for the dissemination, and include how the Contractor plans to address any challenges or findings of the assessments.

c) Types of organizations in the network shall include: transplant centers;

cooperative stem cell registries; cord blood banks; donor centers;

recruitment organizations; cooperative donor registries; marrow and peripheral blood stem cell collection centers; histocompatibility and infectious disease testing laboratories; and tissue repositories.

D00 Plan to coordinate network of organizations

3.3.2 Establish Program Participation Agreement – The Contractor shall, subject to COR approval, require a written participation agreement specific to the functions of each type of organization, foreign or domestic, as a condition of participation in the SPA-CC network. Written agreements from foreign organizations shall be submitted to the COR for approval and not made effective until Department of State approval has been received.

The Contractor shall ensure participating organizations comply with FDA requirements for Investigational New Drug (IND) and Biologics License Applications (BLA) and with the established operating procedures and requirements, whether through participation agreements or other means.

a) Develop criteria, within 60 days after the EDOC, for Program participation and make recommendations to the Working Group regarding an organization’s participation in the SPA-CC. Collaborate with the Program Participation Working Group to develop these criteria.

b) Sent to the COR copies of each participation agreement prior to enactment of each agreement.

c) Subject to COR approval, require a written participation agreement specific to the functions of each type of organization, foreign or domestic, as a condition of participation in SPA-CC. Written agreements from foreign organizations submitted to the COR for approval and not made effective until Department of State approval has been received.

d) Participation agreements require organizations to maintain and make available for audit purposes: 1) financial records and other essential records related to activities under the agreement; and 2) information about patients and donors is collected, stored and made available to the Contractor in a manner that protects the rights and confidentiality of donor and patients; and, individually identifiable information about donors and patients is kept confidential, consistent with Federal requirements (or, in the case of foreign organizations, equivalent requirements in those countries).

e) Ensure participating organizations comply with FDA requirements for Investigational New Drug (IND) and Biologics License Applications (BLA) and with the established operating procedures and requirements, whether through participation agreements or other means. These include requirements for transplant centers to submit outcomes data, as stipulated by the Stem Cell Therapeutic Outcomes Database.

f) Agreements with donor centers shall:

1. Include specific contract language, which states that all data about donors that is necessary to operate the Program shall remain available to the Program as long as the Program is authorized by Federal law.

2. Specify that identifying information about patients, donors and volunteer potential donors who have enrolled in the Program shall be kept confidential within the Program.

3. Not preclude a donor center that participates in the SPA-CC from sharing identifying information about donors or potential donors with the Contractor or with other donor centers that are participants of the SPA-CC in performing Program functions.

4. Provide that identifying information about donors or potential donors shall not be disclosed to transplant centers that are participants of the Program, or disclosed outside the Program, without the consent of the individual.

5. Specify that donors shall be informed that there may be limits on their ability to correspond with the patients who receive their blood stem cells.

6. Not limit the Government right to access all Program data.

g) Participation agreements with transplant centers require reporting outcomes data to the SCTOD.

h) Consult with the COR regarding proposed changes to the participation agreements or criteria having an impact beyond day-to-day operations and ensure that such changes do not conflict with other components of the C.W. Bill Young Cell Transplantation Program and, in the case of National Cord Blood Inventory (NCBI) units, with HRSA requirements for such units. The Contractor shall submit to the COR for approval proposed changes to participation agreements or criteria prior to their adoption and implementation.

D00 Develop criteria and recommendations in collaboration with the

Program Participation Working Group D00 Propose participation agreements between the SPA-CC and both domestic and foreign organizations

3.3.3 Establish Non-Participant Transplant Centers’ Access Procedures - The

Contractor shall establish temporary access procedures by which non-participant transplant centers may, on a limited basis, access potential adult volunteer donors to donate blood stem cells for transplant. The procedures shall include obtaining written assurance from the transplant center that it will submit the required outcomes data. The procedures shall be submitted to the COR for approval. The following table summarizes how participant and non-participant transplant centers may access cord blood units through the SPA-CC.

Participating Centers

Non- Participating

Centers

Written participation agreement required √

Ongoing access to cord blood stem cell sources through the Program

Temporary access to cord blood stem cell sources through the Program

Compliance with outcomes data submission required

a) Submit a document that details procedures by which non-participant transplant centers may, on a limited basis, access potential adult volunteer donors to donate blood stem cells for transplant. The procedures shall include obtaining written assurance from the transplant center that it will submit the required outcomes data and shall be submitted to the COR for approval within 30 days after the EDOC.

D00 Submit a document that details procedures by which non-participant transplant centers may, on a limited basis, access potential adult volunteer donors to donate blood stem cells for transplant

3.3.4 Provide Notification of Participants Not in Compliance - The Contractor shall notify the COR when network participants are determined to no longer be in compliance with the SPA-CC’s standards or requirements. Additionally, the COR shall be notified when exemptions or deviations to specific standards or requirements are granted to participants.

a) Notifies the COR within 30 days when network participants are no longer in compliance with the SPA-CC’s standards or requirements, and when exemptions or deviations to specific standards or requirements are granted to participants.

b) Develop corrective action plan for non-compliant network participants and submit to the COR for review.

D00 Notification of network participants not in compliance with standards or requirements D00 Corrective action plan

3.3.5 Provide Training and Technical Assistance - The Contractor shall provide training and technical assistance to participants of the SPA-CC network. For training the Contractor may convene meetings of the entire network or specific types of network participants (e.g., recruitment organizations, donor center coordinators, transplant center coordinators, donor contact and work-up specialists), when the cost is justified. The Contractor shall provide a mechanism for assuring proficiency for transplant center search coordinators and for other network staff, as needed.

a) Training and technical assistance plan shall be submitted within 90 days after the EDOC and include a timeline for implementation and objective measures of effectiveness. Submit in the annual end-of-performance report the training and technical assistance activities that were performed to the SPA-CC network participants and include how the Contractor plans to address any challenges or findings of the assessments.

D00 Training and technical assistance plan

3.3.6 Conduct Network Participant Satisfaction Survey - The Contractor shall develop and conduct an annual evaluation and feedback system of the network and cord blood banks to determine the extent to which the SPA-CC is meeting the needs of the participating organizations; identify whether additional services are needed; and identify ways in which the system can be improved to best meet the needs of the network and cord blood banks. The Contractor shall ensure the network can provide such feedback anonymously and that the feedback will not influence the network’s relationship with the SPA-CC.

a) Submit a plan that describes the evaluation approach, timeline, and dissemination plan, and make recommendations to address any findings.

The plan also discusses how network participants can provide such feedback anonymously and that the feedback will not influence the bank’s relationship with the SPA-CC.

b) Four (4) weeks prior to the end of the performance period, provide a report to the COR on survey implementation, findings, evaluation methodology, recommendations and action plan to address stakeholders’ concerns, and a subsequent action plan.

c) COR approval obtained before any changes in distribution format or content and prior to survey distribution.

D00 Plan and report on the network participant satisfaction survey

3.4 Facilitate Searches and Transplants and Provide a Single Point of Access

3.4.1 Specify Search Data Content and Format - The Contractor shall work with transplant centers to specify the content and format of the data required for running searches and interpreting search results and needed for each potential volunteer donor and for each cord blood unit (HRSA funded units in the NCBI and others) to be made available for transplantation through the SPA-CC.

a) Provide report on the specifications of the content and format of the data required for running searches and interpreting search results and needed for each potential volunteer donor and for each cord blood unit (HRSA funded units in the National Cord Blood Inventory and others) to be made available for transplantation through the SPA-CC. This shall be completed within 6 days after the EDOC.

b) Data specifications shall include the tissue typing necessary for inclusion in the searchable inventory and for confirmatory tests, including the level of specificity, typing methodology, and presentation of the information.

c) Data specifications developed in collaboration with transplant centers, cord blood banks, histocompatibility experts, the SPA-CC, and other identified stakeholders.

d) The format, procedures, and data submission requirements is the same as those employed by the incumbent contractor and the Stem Cell Therapeutic Outcomes Database (SCTOD) for the of the C.W. Bill Young Cell Transplantation Program, or other established organizations proficient in collecting data on the outcomes of blood stem cell transplants.

e) Prior to implementation and upon each revision, provide a written report to the COR detailing the proposed specifications.

D00 Plan to make data on potential volunteer donors and cord blood units available through a single point of access D00 Data specifications report

3.4.2 Establish and Use Search Algorithms - The Contractor shall work with transplant centers, cord blood banks, and other appropriate parties to utilize an automated process that uses a single algorithm for human leukocyte antigen (HLA) matching and other search criteria to display the suitable adult volunteer donors and cord blood units in rank order and according to established criteria.

The algorithms shall reliably identify and prominently flag instances in which the patient’s previously donated bone marrow or cord blood unit may have been identified as a possible match (e.g., mechanism for cross-referencing donated cord blood and patient’s HLA, date of birth, and gender).

a) Within 30 days after the EDOC, submit automated-process report that includes all information pertinent to transplant center selection of a potential volunteer adult donor or cord blood unit for follow-up testing and procurement, including the name of the cord blood bank holding the unit.

1. Automated-process report describes a programmed process for displaying, in rank order and according to established criteria, suitable adult volunteer donors and suitable cord blood units for a physician searching on behalf of a patient.

2. Automated-process allows transplant centers to customize the search criteria and contains the capability to utilize bioinformatics tools to assist physicians in predicting which potential volunteer adult donors or cord blood units are likely, upon further testing, to be suitable matches for a physician searching on behalf of a patient at additional loci or alleles.

3. Automated-process facilitates selection of multiple potential volunteer adult donors and cord blood units for a single patient and reliably identifies and prominently flags instances in which the patient’s previously donated bone marrow or cord blood unit may have been identified as a possible match.

b) Annually assess the need for providing additional services to transplant centers and incorporate these services in the selection algorithms.

D00 Automated process report

3.4.3 Establish Plan for Compiling Search Results - The Contractor shall establish a plan for rank-ordering potential matches in an unbiased fashion, consolidating search results into reports, and providing those reports to healthcare providers, including non-transplant physicians, and patients. The Contractor shall offer transplant centers expert histocompatibility/search consultation, including recommendations regarding the strategy for evaluating and selecting potential adult marrow donors and CBUs.

In terms of rank-ordering, a computer-based human leukocyte antigen (HLA) selection process may be employed, if it is shown to be equal or superior to an expert consultant, or a combination of computer based selection and expert consultation may be utilized for rank-ordering the potential matches in an unbiased fashion with regard to stem cell source. Whether a consultant, alone, or in collaboration with computer based HLA selection approach is used, the Contractor’s process shall enable transplant centers and physicians to customize search criteria and utilize bioinformatics tools to more accurately predict which blood stem cell source is likely, upon further testing, to be a suitable match for a physician searching on behalf of a patient.

a) Within 30 days after the EDOC, establish a plan for consolidating search results into reports and for providing those reports to healthcare providers, including non-transplant physicians, and patients and offer transplant centers expert histocompatibility/search consultation, including recommendations regarding the strategy for evaluating and selecting potential adult marrow donors and CBU.

b) Search results compilation plan shall:

1. address search results that include compatible adult donor and cord blood units that are clearly marked as reserved for other patients.

2. include contractor’s process enables transplant centers and physicians to customize search criteria and utilize bioinformatics tools to more accurately predict which blood stem cell source is likely, upon further testing, to be a suitable match for a physician searching on behalf of a patient.

3. convey that the contractor’s process facilitates selection of multiple cord blood units for one patient when appropriate and reliably identifies and prominently flags instances in which a physician searching on behalf of a patient’s own previously donated cord blood unit, or previous listing as a volunteer donor, may have been identified as a compatible graft (e.g., mechanism for cross-referencing donated cord blood or potential adult marrow donor with patient’s human leukocyte antigen type, date of birth, and gender).

D00 Search results consolidation plan

3.4.4 Establish Reservation Policies and Disclosures Procedures - The Contractor, in collaboration with transplant centers and cord blood banks, shall establish written policies and procedures through which a transplant center can request further testing and/or make an exclusive and firm reservation of a donor or CBU units (including multiple cord blood units) for transplantation, for a maximum of six (6) months.

a) Within 30 days after the EDOC, establish written policies and procedures through which a transplant center can request further testing and/or make an exclusive and firm reservation of a donor or CBU for transplantation for a maximum of six (6) months.

b) The reservation and policies disclosures shall:

1. require that search results that include compatible adult donor and cord blood units that are clearly marked as reserved for other patients.

2. remind transplant physicians of reservations held on behalf of their patients that will expire soon and that allow transplant physicians to provide mandatory justifications for renewing or extending reservations.

3. provide for notifying transplant physicians that have expressed interest in reserved cord blood units or donors if reservations are cancelled or expired and procedures shall ensure that a reserved CBU or donor is not made available to another transplant center while the reservation is effective.

4. include a means for terminating reservations for potential adult bone marrow donors or cord blood units if they are not utilized within a specified timeframe, always notifying the transplant center prior to release and providing an opportunity to extend the reservation when justified.

D00 Reservation policies and disclosures

3.4.5 Develop Process for Distribution of Cord Blood Units - The Contractor shall develop a process for facilitating the distribution of cord blood units for transplantation. The Contractor shall submit to the COR for approval, prior to its implementation, an updated description of this process for facilitation, including the roles and responsibilities of each party and the chain of custody from the storage freezer at the bank to the transplant center.

a) Within 45 days after the EDOC, develop a process for facilitating the distribution of cord blood units for transplantation.

b) Submit to the COR for approval, prior to its implementation, an updated description of this process for facilitation, including the roles and responsibilities of each party and the chain of custody from the storage freezer at the bank to the transplant center.

D00 Description of process for facilitating the distribution of cord blood units for transplantation

3.4.6 Develop Quality Control Plan regarding Search Reports - The Contractor shall develop and implement, a quality control plan regarding search reports and other information provided to patients and physicians electronically through the

SPA-CC.

a) Within 45 days after the EDOC, establish written policies and procedures through which a transplant center can request further testing and/or make an exclusive and firm reservation of a donor or CBU for a maximum of six months.

b) Develop and implement, in consultation with transplant centers, a quality control plan regarding search reports and other information provided to patients and physicians electronically through the SPA-CC.

c) Quality control plan shall:

1. Address the utility and accuracy of information, including updating cord blood unit documentation and adult donor status, correcting discrepancies or inaccuracies, and deleting units or adults listed that are no longer acceptable or medically eligible for transplant.

2. Describe any special studies to be conducted to determine the quality of the information available through the SPA-CC and/or to analyze quality control alternatives.

3. Include a timeline for implementation and objective measures of effectiveness, and include how the Contractor plans to address any challenges or findings of the assessments.

d) The Contractor shall submit updated revisions to the plan to the COR for approval prior to implementation.

D00 Quality control plan regarding search reports

3.4.7 Audit Search Reports - The Contractor shall propose and implement a process for reviewing how adult bone marrow donors and cord blood units were ranked for a sample of patients. The Contractor shall provide the COR and participating donor centers, cord blood banks, and transplant centers with a report detailing the auditing procedures used as well as the findings from each of these reviews.

a) Within 45 days after the EDOC, provide the COR and participating donor centers, cord blood banks, and transplant centers with an audit search report detailing the auditing procedures used as well as the findings from each of these reviews.

b) Prior to implementation, obtain COR approval, for updates or changes to audit criteria.

D00 Audit search reports

3.5 Donor Recruitment and Retention Activities

3.5.1 Submit Annual Recruitment and Retention Plan - The Contractor shall submit to the COR for approval an annual recruitment and retention plan (including goals in absolute numbers) for broad population groups consistent with the collecting and reporting requirements of the Office of Management and Budget.

The Contractor shall provide the COR with a plan for achieving those goals and the goals shall be set so as to increase minority volunteers, add unique phenotypes and replace volunteers lost through attrition, consistent with funds available. The Contractor shall negotiate annual recruitment goals with each recruitment organization. Upon approval, the Contractor shall implement the plan. The Contractor shall submit updated revisions to the plan to the COR for

a) Within 90 days after the EDOC, submit to the COR for approval annual recruitment and retention plan for broad population groups consistent with the collecting and reporting requirements of the Office of Management and Budget.

b) The annual recruitment and retention plan shall:

1. Detail recruitment goals, including with respect to increasing racial and ethnic minority group representation in the enrollment of the Program

2. Discuss goals to increase the likelihood that potential donors will be available to donate blood stem cells if requested by a physician searching on behalf of a patient.

3. Discuss how technology, including a mobile application, will be leveraged to engage in the recruitment of cord blood unit and potential adult volunteer donors.